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Human Factors for Combination Products
Medical Devices
Combination Products

Human Factors for Combination Products

Date to be announced

Contact us for more info
Price available after dates are announced

TRAINING TIMES

  • TBDVienna
  • TBDLondon
  • TBDNew York
  • TBDLos Angeles
Online Training



LEARNING OBJECTIVES

Learning Objective

Understand the definitions and key concepts of human factors and combination products.

Understand the definitions and key concepts of human factors and combination products.

Learning Objective

Recognize the regulatory and standards landscape for combination products.

Recognize the regulatory and standards landscape for combination products.

Learning Objective

Conduct comprehensive risk assessments to identify potential hazards.

Conduct comprehensive risk assessments to identify potential hazards.

Learning Objective

Integrate risk management processes using the ISO14971 framework.

Integrate risk management processes using the ISO14971 framework.

Learning Objective

Perform formative assessments to evaluate early design concepts.

Perform formative assessments to evaluate early design concepts.

Learning Objective

Develop and implement study designs for human factors evaluation.

Develop and implement study designs for human factors evaluation.

Learning Objective

Integrate ergonomics into the design of combination products.

Integrate ergonomics into the design of combination products.

Learning Objective

Conduct summative assessments and interpret results to enhance product safety and usability.

Conduct summative assessments and interpret results to enhance product safety and usability.

Learning Objective

Prepare summary documentation for regulatory submissions.

Prepare summary documentation for regulatory submissions.

Learning Objective

Understand how regulatory agencies evaluate human factors and ergonomics requirements.

Understand how regulatory agencies evaluate human factors and ergonomics requirements.



KEY TOPICS

Regulatory and Standards Overview
EMA & FDA
IEC62366
HE75
ISO14971
ISO13485
Key guidance documents including the FDA human factors Guidance
User-Centered Design Process
Study Design for Human Factors
Summative Assessment
Regulatory Evaluation (Regulators and Notified Bodies)

TRAINER

James Pink

James Pink

Health Sciences and Medical Devices Consultant

James Pink has over 25 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assuranceprograms for active and non-active implantable and combination products. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.

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Video Invitation

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